Liofilchem, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Gepotidacin GEP 10 µg510(k)Jul 23, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 23, 2026
Ceftobiprole BPR 5 µg Disc510(k)Jun 23, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 23, 2025